Status:
COMPLETED
Irinotecan, Fluorouracil, and Leucovorin in Treating Patients With Advanced Gastrointestinal Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anal Cancer
Carcinoma of the Appendix
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from ...
Detailed Description
OBJECTIVES: Primary * To determine the maximum tolerated dose of irinotecan hydrochloride in FOLFIRI for each respective UGT1A1 TA indel genotype grouping (group 1 \[7/7, 7/8, 8/8\], group 2 \[6/7, ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Biopsy confirmed diagnosis of gastrointestinal cancer
- Advanced, unresectable disease
- Confirmation of UGT1A1 TA indel genotype
- Measurable or evaluable (non-measurable) disease
- Measurable disease is defined as ≥ 1 lesion that can be accurately measured (longest diameter to be recorded) as ≥ 2.0 cm with conventional techniques or as ≥ 1.0 cm with spiral CT scan
- Clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules, palpable lymph nodes)
- Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung
- The following are considered non-measurable disease:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusions
- Lymphangitis cutis/ pulmonis
- Inflammatory breast disease
- Abdominal masses (not followed by CR scan or MRI)
- Cystic lesions
- All other lesions (or sites of disease), including small lesions (longest diameter \< 2.0 cm with conventional techniques or as \< 1.0 cm with spiral CT)
- No known central nervous system metastases or carcinomatous meningitis
- PATIENT CHARACTERISTICS:
- Inclusion criteria
- Life expectancy ≥ 12 weeks.
- ECOG performance status 0-2
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- SGOT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if liver metastases)
- Total Bilirubin ≤ ULN for patients in group 3 and ≤ 2.0 times ULN for patients in groups 1 and 2
- Hemoglobin ≥ 9.0 g/dL
- Creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for the duration of study treatment
- Willing to provide blood samples for mandatory translational studies
- Exclusion criteria
- Known allergy to irinotecan hydrochloride-related agents (e.g., topotecan), 5-fluorouracil, and/or leucovorin calcium
- Active or uncontrolled infection
- Evidence of serious intercurrent illness (e.g., unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)
- PRIOR CONCURRENT THERAPY:
- Recovered from all toxicities
- More than 4 weeks since prior major surgery
- More than 2 weeks since completion of prior radiotherapy
- No prior radiotherapy to \> 25% of bone marrow
- More than 2 week since prior cytotoxic chemotherapy, biologic therapy, or immunotherapy
- No concurrent sargramostim (GM-CSF)
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00654160
Start Date
June 1 2008
End Date
December 3 2012
Last Update
May 25 2017
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905